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PN EN ISO 13408-6 : 2011 AMD 1 2013

Withdrawn

Withdrawn

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)

Published date

01-12-2013

Withdrawn date

10-20-2021

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Describes the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.

Committee
TC 295
DevelopmentNote
Supersedes PN EN 13824. (12/2011) Polish translation issued on 24/01/2013. AMD 1 2013 is only available in English. (09/2013) Polish translation of AMD 1 issued on 12/06/2015. (06/2015)
DocumentType
Standard
PublisherName
Polish Committee for Standardization
Status
Withdrawn
Supersedes

Standards Relationship
ISO 13408-6:2005 Identical

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